01.05.23 -- 3 Tips For Improving Pharmacovigilance Agreements

The shifting landscape of industry innovation and unconventional partnerships has created a need for an increased number of pharmacovigilance agreements (PVAs) with higher levels of complexity. As a result, many stakeholders face new challenges in drafting, negotiating, and finalizing PVAs.

Explore the important roles of the project manager, clinical supply manager, and financial project analyst, whose responsibilities contribute to clinical supply expertise and study success.

Our industry must examine whether — and how — we support physicians and clinical trial sites, who work under constant pressure related to timelines, data quality, and patient care.

Sikich SuiteSuccess for CROs can completely transform the CRO business with resource management and finance. Explore some ways SuiteSuccess for CROs helps you control and build CRO business growth.

With the greater emphasis on patient centricity, patients are valued as an active participant in their own care. There is an increased emphasis on evaluating treatment benefit using patient-centric concepts and input from the patient community. Regulators now urge sponsors and researchers to systematically engage patients and caregivers to define the disease burden and unmet needs.

With smartphones now ubiquitous, read about how interest has increased in digital health solutions such as telemedicine platforms and apps used to track symptoms or medication usage.

In this white paper, explore the development process, regulatory landscape, and pathways to approval for medical devices to help sponsors optimize the likelihood of commercial success.

This e-book is designed to help prepare for an upcoming FDA inspection, outlining what to expect during the investigation and strategies to employ as the investigation process comes to a close.

Learn about Annex VI, which covers changes in the labeling requirements for investigational medicinal products (IMPs) and harmonizes them throughout EU countries.

In this webinar, gain insight into the latest regulatory and clinical developments in the field of oncology, and the similarities and differences between the Chinese oncology market and the overall global market.

In January 2022, EU (536/2014) — a binding regulation across all members of the EU — came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.

The Advarra eRegulatory Management System (Advarra eReg) provides integrated protocol, staff, and institution documentation to streamline regulatory processes and enhance compliance.